Product code FFK— Gastroenterology, Urology
1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
- Classification name
- Lithotriptor, Electro-Hydraulic
- Device class
- Class 2
- Regulation
- 21 CFR 876.4480
- Advisory panel
- Gastroenterology, Urology
- Total cleared
- 61
- First cleared
- Most recent
Market context for product code FFK
FDA has cleared devices under product code FFK between 1980 and 2025, filed by 26 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2025
- 2023
- 2021
- 2019
- 2016
- 2013
- 2012
- 2010
- 2007
- 2005
- 2001
- 2000
- 1999
- 1998
- 1997
Top applicants under product code FFK
Recent clearances under product code FFK
- K242888 — Electrohydraulic Lithotriptor (TCS-B3-II)
- K243032 — EHL Probe (3 models)
- K230488 — EL27-Compact; Sterile EHL-Probes
- K202813 — URO-TOUCH 9 French Probe
- K191124 — Swiss LithoClast Trilogy
- K162119 — UreTron PF Series Probe
- K160198 — UreTron MultiProbe Lithotripter System
- K132795 — CYBERWAND STERILE PROBE SET
- K130368 — AUTOLITH TOUCH; URO TOUCH
- K123038 — SWISS LITHOBREAKER
- K120303 — CYBERWAND DUAL ACTION ULTRASONIC LITHOTRIPSY SYSTEM
- K111058 — URETRON MODEL URT
- K102169 — CYBERWAND LITHOTRIPTER
- K092033 — VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR
- K072422 — CYBERWAND STERILE PADS, MODEL: CW-RBPBX
- K062475 — LMA STONEBREAKER DEVICE; PROBE SIZE 1.0MM, 1.6MM, 2.0MM
- K052135 — CYBERSONICS CYBERWAND DUAL PROBE LITHOTRIPTER
- K011911 — SUCTION PUMP FOR INTRACORPOREAL ULTRASOUND LITHOTRIPTER AND ACCESSORIES, MODEL 2207.XXX
- K011848 — CIRCON AEH-4 ELECTROHYDRAULIC LITHOTRIPSY PROBE
- K012445 — EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA)
- K011065 — INTRACORPOREAL ULTRASOUND LITHOTRIPTER, MODEL 2271.004, ULTRASOUND TRANSDUCER, MODEL 2271.501, ULTRASOUND PROBES (SONO)
- K002084 — MICROVASIVE LITHOTRIPTOR FLEXPROBE II
- K992114 — KSEA CALCUSPLIT
- K992251 — SWISS LITHOCLAST MULTIPURPOSE PROBE
- K990341 — ELECTRO MECHANICAL LITHOTRIPTOR
- K980492 — AEH-3 ELECTROHYDRAULIC LITHOTRIPTER AND PROBES (E-1F, E-3F, E-5F, AND E-9F)
- K981233 — KSEA CALCUSPLIT
- K974796 — LITHOSPEC(TM) INTRACORPOREAL LITHOTRIPTER
- K973788 — MICROVASIVE LIPTHOTRIPSY PROBES
- K974164 — SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE
- K963285 — EMS SWISS LITHOCLAST LITHOTRIPTER
- K951531 — SWISS LITHOCLAST LITHOTRIPTER
- K944571 — PULSE GUARD 3FR ELECTRODE
- K931755 — RIWOLITH 2280 PROBES
- K931779 — EHL PULSE GENERATOR
- K920410 — EMILITH ELECTROMECHANICALIMPACTOR LITHOTRIPSY PROB
- K925396 — PULSE GUARD ELECTRODE
- K923822 — AUTOLITH-IEHL
- K914517 — SD-200IEHL(TM)
- K913487 — RIWOLITH 2280
- K914515 — 3 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
- K914516 — 9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
- K914514 — 1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
- K913955 — 1.9 FRENCH LITHOTRIPTER ELECTRODE, MODIFICATION
- K905553 — LITHOTRIPTOR SYSTEM MODEL 27080
- K903337 — 1.9 FRENCH LITHOTRIPTER ELECTRODE
- K894704 — 2.5 FRENCH LITHOTRIPTOR ELECTRODE
- K895178 — TECHNOMED PULSOLITH LASER SYSTEM
- K885255 — MDL-1 LASERTRIPTER(TM)
- K890436 — TECHNOMED PULSOLITH LASER SYSTEM
- K883189 — MODEL 27080 CALCUTRIPT ELECTROHYDRAULIC LITHR SYS
- K880503 — MDL-1 LASERTRIPTER
- K864904 — 3F ELECTRODE
- K863642 — CANDELA MODEL MDL-1 LASER LITHOTRIPTOR
- K852874 — 5F ELECTRODE(LITHOTRIPTOR)
- K834228 — LITHOTRIPTOR ELECTRODE 4.5F
- K832566 — COAXIAL ELECTRODE #300A
- K830086 — 4.5 F LITHOTRIPTOR ELECTRODE
- K822585 — LITHOTRIPTOR ELECTRODE 4.5F
- K822644 — RIWOLITH 2135
- K802322 — MODEL SD-1 DISINTEGRATOR
Data sourced from openFDA. This site is unofficial and independent of the FDA.